Safety of omalizumab in the treatment of moderate-to-severe bronchial asthma

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Abstract

This review aimed to analyze national and international literature on the safety of omalizumab in the treatment of moderate-to-severe bronchial asthma. Omalizumab is one of the longest-standing monoclonal antibodies and the first available treatment option for severe allergic asthma in patients aged ≥6 years. Several randomized controlled studies have established its efficiency and safety, leading to its final registration more than 15 years ago. In most cases, long-term treatment with omalizumab is safe without increasing the risk of adverse reactions. However, over the years, a growing trend has been observed in several registrations of adverse events associated with the use of omalizumab. A review of the literature revealed a lack of long-term clinical monitoring data (over 2 years) in both patients aged >18 years and children. Long-term adverse reactions during omalizumab therapy are insufficiently examined and require more detailed analysis, despite reports of an association between omalizumab and some adverse events. Moreover, extremely few cases of adverse reactions to omalizumab were reported in the Russian Federation. Thus, further investigations of the safety profile of omalizumab and monitoring of its delayed adverse reactions are required.

About the authors

Ksenia O. Shnaider

Pirogov Russian National Research Medical University

Author for correspondence.
Email: ks.shnaider@mail.ru
ORCID iD: 0000-0002-0630-4238
Russian Federation, Moscow

Maksim L. Maksimov

Pirogov Russian National Research Medical University; Russian Medical Academy of Continuous Professional Education; Kazan State Medical Academy — Branch Campus of Russian Medical Academy of Continuous Professional Education

Email: maksim_maksimov@mail.ru
ORCID iD: 0000-0002-8979-8084

MD, Dr. Sci. (Med.), professor

Russian Federation, Moscow; Moscow; Kazan

Boris K. Romanov

Pirogov Russian National Research Medical University

Email: bkr@ya.ru
ORCID iD: 0000-0001-5429-9528

MD, Dr. Sci. (Med.), professor

Russian Federation, Moscow

References

  1. Ginasthma.org [Internet]. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention [cited 2022 May 10]. Available from: www.ginasthma.org
  2. Klinicheskie rekomendatsii Ministerstva Zdravookhraneniya Rossiiskoi Federatsii: Bronkhial'naya astma. Available from: https://raaci.ru/dat/pdf/allergic_rhinitis.pdf. Accessed: 10.05.2022.
  3. Namazova-Baranova LS, Vishneva EA, Dobrynina EA, et. al. Primary results of long-term dynamic monitoring of children with bronchial asthma of uncontrolled severe persistent course. Pediatric pharmacology. 2016; 13(6):554–559. doi: 10/15690/pf.v13i6.1668. (In Russ).
  4. Cdc.gov/asthma/most_recent_data.htm [Internet]Centers for Disease Control and Prevention, Asthma Data. [cited 2022 May 10]. Available from: http://www.cdc.gov/asthma/most_recent_data.htm
  5. Pawankar R. Allergic diseases and asthma: a global public health concern and a call to action. World Allergy Organization Journal. 2014;7(1):12. doi: 10.1186/1939-4551-7-12
  6. Tsai M-K, Lin Y-C, Huang M-Y, et al. The effects of asthma medications on reactive oxygen species production in human monocytes. J Asthma. 2017;55(4):345–353. doi: 10.1080/02770903.2017.1339798
  7. Holguin F, Cardet JC, Chung KF, et al. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2020;55(1). doi: 10.1183/13993003.00588-2019
  8. Mitskevich SE, Fedorov IA, Chuprynina AI, Rybakova OG. Use of Omalizumab in Management of Severe Uncontrolled Bronchial Asthma in Children. Doctor.Ru. 2020;19(3):53–56. doi: 10.31550/1727-2378-2020-19-3-53-56
  9. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2013;43(2):343-373. doi: 10.1183/09031936.00202013
  10. Abraham I, Alhossan A, Lee CS, et al. 'Real-life' effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review. Allergy. 2016;71(5):593–610. doi: 10.1111/all.12815
  11. Federal'nye klinicheskie rekomendatsii po okazaniyu meditsinskoi pomoshchi detyam s bronkhial'noi astmoi. Available from: https://www.vodkb.ru/wp-content/uploads/2017/03/brast.pdf. Accessed: May 10, 2022. (In Russ).
  12. Il'ina NI, Namazova-Baranova LS, Emel’yanov AV et al. Algoritm naznacheniya immunobiologicheskikh preparatov pri tyazheloi atopicheskoi bronkhial’noi astme v Rossii (soglasitel'nyi dokument). Rossiiskii allergologicheskii zhurnal. 2014. (4):26–27. (In Russ).
  13. Darveaux J, Busse WW. Biologics in Asthma–The Next Step Toward Personalized Treatment. J Allergy Clin Immunol Pract. 2015;3(2):152–160. doi: 10.1016/j.jaip.2014.09.014
  14. Licari A, Marseglia A, Caimmi S, et al. Omalizumab in Children. Paediatr Drugs. 2014;16(6):491–502. doi: 10.1007/s40272-014-0107-z
  15. Grls.rosminzdrav.ru/default.aspx. Instruktsiya po primeneniyu preparata omalizumab. Available from: https://grls.rosminzdrav.ru/default.aspx. Accessed: May 10, 2022. (In Russ).
  16. Kurbacheva OM, Galitskaya MA. The place of Omalizumab in the treatment of allergic diseases. Medical Council. 2019(15):38–49. doi: 10.21518/2079-701x-2019-15-38-49
  17. Licari A, Manti S, Castagnoli R, et al. Targeted Therapy for Severe Asthma in Children and Adolescents: Current and Future Perspectives. Paediatr Drugs. 2019;21(4):215–237. doi: 10.1007/s40272-019-00345-7
  18. Odajima H, Ebisawa M, Nagakura T, et al. Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma. Allergol Int. 2017;66(1):106–115. doi: 10.1016/j.alit.2016.06.004
  19. Simpson CR, Sheikh A. Trends in the epidemiology of asthma in England: a national study of 333,294 patients. J R Soc Med. 2010;103(3):98–106. doi: 10.1258/jrsm.2009.090348
  20. Noop A, Johansson SG, Adedoyin J. et al. After 6 years with Xolair; 3-year withdrawal follow-up. Allergy. 2010;(1):156–160. doi: doi.org/10.1111/j.1398-9995.2009.02144.x
  21. Niven RM, Saralaya D, Chaudhuri R, et al. Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: a UK multicentre observational study (the APEX II study). BMJ Open. 2016;6(8). doi: 10.1136/bmjopen-2016-011857
  22. Strel’tsov EA, Demidov VS, Tsoy LV, et al. Safety and efficiency of using Omaulizumab in bronchial asthma. Medical Herald of the South of Russia. 2019;10(2):6–12. doi: 10.21886/2219-8075-2019-10-2-6-12
  23. Vishneva EA, Namazova-Baranova LS, Dobrynina EA, et al. The Long-Term Omalizumab Therapy in Children with Severe Persistent Uncontrolled Asthma: Evaluation of the Outcomes According to the Data of the Hospital Patient Registry. Pediatric pharmacology. 2018;15(2):149-158. doi: 10.15690/pf.v15i2.1877
  24. Melikhov OG. Klinicheskie issledovaniya. 3-e izdanie dopolnennoe. Moscow: Atmosfera; 2013.
  25. Sousa J, Taborda-Barata L, Monteiro C. Biological therapy-associated adverse reactions in asthma: analysis of reporting to the Portuguese pharmacovigilance system. Expert Opin Drug Safe. 2019;19(1):99–106. doi: 10.1080/14740338.2020.1686481
  26. Di Bona D, Fiorino I, Taurino M, et al. Long-term "real-life" safety of omalizumab in patients with severe uncontrolled asthma: A nine-year study. Respir Med. 2017;130:55–60. doi: 10.1016/j.rmed.2017.07.013
  27. Li L, Wang Z, Cui L, et al. Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab. Clin Transl Allergy. 2021;11(4). doi: 10.1002/clt2.12038
  28. Bian S, Zhang P, Li L, et al. Anaphylaxis Associated With Allergen Specific Immunotherapy, Omalizumab, and Dupilumab: A Real World Study Based on the US Food and Drug Administration Adverse Event Reporting System. Front Pharmacol. 2021;12. doi: 10.3389/fphar.2021.767999
  29. Lieberman PL, Jones I, Rajwanshi R, et al. Anaphylaxis associated with omalizumab administration: Risk factors and patient characteristics. J Allergy Clin Immunol. 2017;140(6):1734–1736.e1734. doi: 10.1016/j.jaci.2017.07.013
  30. Harrison RG, MacRae M, Karsh J, et al. Anaphylaxis and serum sickness in patients receiving omalizumab: reviewing the data in light of clinical experience. Ann Allergy, Asthma Immunol. 2015;115(1):77–78. doi: 10.1016/j.anai.2015.04.014
  31. Lieberman PL, Umetsu DT, Carrigan GJ, Rahmaoui A. Anaphylactic reactions associated with omalizumab administration: Analysis of a case-control study. J Allergy Clin Immunol. 2016;138(3):913–915.e912. doi: 10.1016/j.jaci.2016.03.030
  32. Limb SL, Starke PR, Lee CE, Chowdhury BA. Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma. J Allergy Clin Immunol. 2007;120(6):1378–1381. doi: 10.1016/j.jaci.2007.09.022
  33. Nazir S, Tachamo N, Fareedy SB, et al. Omalizumab-associated eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). Ann Allergy, Asthma Immunol. 2017;118(3):372–374.e371. doi: 10.1016/j.anai.2016.12.003.
  34. Winchester DE, Jacob A, Murphy T. Omalizumab for Asthma. N Engl J Med. 2006;355(12):1281-1282. doi: 10.1056/NEJMc061914
  35. Bargagli E, Rottoli P. Omalizumab Treatment Associated with Churg-Strauss Vasculitis. Int Arch Allergy Immunol. 2008;145(3):268–268. doi: 10.1159/000109296
  36. Yamaki Y, Hayashi D, Honda K, et al. A case of omalizumab-associated eosinophilic granulomatosis with polyangiitis. Pediatr Int. 2021;63(9):1119–1121. doi: 10.1111/ped.14540
  37. Elhadari S, Hammad M. Transient eosinophilic granulomatosis with polyangiitis-like vasculitis during omalizumab therapy: a case report. Open Access Rheumatol. 2020;12:127–131. doi: 10.2147/oarrr.s259746
  38. Carson LN, Pradhan A, Subramanian D. Omalizumab-associated eosinophilic granulomatosis with polyangiitis: cause or coincidence? BMJ Case Rep. 2021;14(7). doi: 10.1136/bcr-2020-240078
  39. Bekcibasi M, Barutcu S, Celen MK, et al. Churg-Strauss syndrome occurring during omalizumab treatment. Eur J Rheumatol. 2015;2(3):129–130. doi: 10.5152/eurjrheum.2015.0086
  40. Lau EMT, Cooper W, Bye PT, Yan K. Difficult asthma and Churg-Strauss-like syndrome: A cautionary tale. Respirology. 2011;16(1):180–181. doi: 10.1111/j.1440-1843.2010.01884.x
  41. Szwarc D, Veillon F, Moser T, et al. Syndrome de Churg et Strauss sous omalizumab : une manifestation viscérale exceptionnelle. J Radiol. 2009;90(11):1737–1739. doi: 10.1016/s0221-0363(09)73273-1
  42. Cazzola M, Mura M, Segreti A, et al. Eosinophilic pneumonia in an asthmatic patient treated with omalizumab therapy: forme-fruste of Churg-Strauss syndrome? Allergy. 2009;64(9):1389–1390. doi: 10.1111/j.1398-9995.2009.02061.x
  43. Wechsler ME, Wong DA, Miller MK, Lawrence-Miyasaki L. Churg-Strauss Syndrome in Patients Treated With Omalizumab. Chest. 2009;136(2):507–518. doi: 10.1378/chest.08-2990
  44. Puéchal X, Rivereau P, Vinchon F. Churg–Strauss syndrome associated with omalizumab. Eur J Intern Med. 2008;19(5):364–366. doi: 10.1016/j.ejim.2007.09.001
  45. Bargagli E, Madioni C, Olivieri C, et al. Churg-Strauss Vasculitis in a Patient Treated with Omalizumab. J Asthma. 2009;45(2):115–116. doi: 10.1080/02770900701767704
  46. Ruppert A-M, Averous G, Stanciu D, et al. Development of Churg-Strauss syndrome with controlled asthma during omalizumab treatment. J Allergy Clin Immunol. 2008;121(1):253–254. doi: 10.1016/j.jaci.2007.10.040
  47. Borekci S, Aydin O, Hatemi G, Gemicioglu B. Development of eosinophilic granulomatosis with poliangiitis (Churg-Strauss syndrome) and brain tumor in a patient after more than 7 years of omalizumab use: A case report. Int J Immunopathol Pharmacol. 2015;28(1):134–137. doi: 10.1177/0394632015572567
  48. Spina MF, Miadonna A. Role of omalizumab and steroids in Churg-Strauss syndrome. J Allergy Clin Immunol. 2009;124(3):600–601. doi: 10.1016/j.jaci.2009.05.023.
  49. Puéchal X, Rivereau P, Vinchon F. Churg–Strauss syndrome associated with omalizumab. Eur J Intern Med. 2008;19(5):364–366. doi: 10.1016/j.ejim.2007.09.001
  50. Solèr M. Omalizumab for Severe Allergic Asthma: 7 Years and Open Questions. Respiration. 2014;88(2):158–161. doi: 10.1159/000360771
  51. Canzian A, Venhoff N, Urban ML, et al. Use of Biologics to Treat Relapsing and/or Refractory Eosinophilic Granulomatosis With Polyangiitis: Data From a European Collaborative Study. Arthritis Rheumatol. 2021;73(3):498–503. doi: 10.1002/art.41534
  52. Basta F, Mazzuca C, Nucera E, et al. Omalizumab in eosinophilic granulomatosis with polyangiitis: friend or foe? A systematic literature reviews. Clin Exp Rheumatol. 2020;38(124):214-220
  53. Mota D, Rama TA, Severo M, Moreira A. Potential cancer risk with omalizumab? A disproportionality analysis of the WHO’s VigiBase pharmacovigilance database. Allergy. 2021;76(10):3209–3211. doi: 10.1111/all.15008
  54. Iribarren C, Rothman KJ, Bradley MS, et al. Cardiovascular and cerebrovascular events among patients receiving omalizumab: Pooled analysis of patient-level data from 25 randomized, double-blind, placebo-controlled clinical trials. J Allergy Clin Immunol. 2017;139(5):1678–1680. doi: 10.1016/j.jaci.2016.12.953

Copyright (c) 2022 Shnaider K.O., Maksimov M.L., Romanov B.K

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